Search Results

The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System

The EasySpray and Spray Set system represents minor design modifications to the TISSOMAT and Spray Set, 510(k) K981089. The purpose of the design modifications is to accommodate a change in the location of the gas on/off function of the system. The original TISSOMAT and Spray Set design includes a foot pedal to turn the gas flow on and off. The EasySpray and Spray Set system moves the control from a foot pedal, to a clip that attaches to the back end of the DUPLOJECT.

The provided 510(k) summary (K050495) for the EasySpray and Spray Set for TISSEEL (Fibrin Sealant) focuses on demonstrating substantial equivalence to a predicate device through minor design modifications. It does not include specific acceptance criteria or performance studies in the way one might expect for a diagnostic or AI-driven device. The submission primarily addresses the change in the gas on/off function's location from a foot pedal to a clip.

Therefore, the requested information elements related to performance studies (like sample size, ground truth, expert opinions, MRMC studies, and training set details) are not applicable or present in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission describes a design modification to a medical device's control mechanism, not a study evaluating performance against a test set of data (e.g., in diagnostics). The demonstration of substantial equivalence relies on the nature of the design change being minor and not affecting fundamental technology or intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no "test set" in the context of data requiring expert ground truth in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no "test set" requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm; it is a mechanical accessory for applying fibrin sealant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There was no "ground truth" established from clinical data or expert consensus in this submission. The "truth" considered by the FDA in granting substantial equivalence was that the design modifications were minor and did not change the device's fundamental function, safety, or effectiveness compared to its predicate.

8. The sample size for the training set

Not applicable. There was no training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. There was no training set and thus no ground truth established for it.

Ask a specific question about this device

The Crosseal™ Application Device is intended for the simultaneous topical application of the two biological components of Crosseal™ Fibrin Sealant via dripping (no air pressure) or via spraying (with air pressure utilizing the pressure regulator unit) onto the surface of the liver in patients undergoing liver surgery.

The Crosseal" Application Device is a sterile, single-use, disposable two-syringe device used for the application by dripping or spraying of the two biological components of Crosseal "Fibrin Sealant onto the surface of the liver in patients undergoing liver surgery. . The two syringes are connected to either a dual (nonspraying) or tri-lumen (spraying) catheter. The device also has two Mixject Dispensing Pins with Detachable Vial Holders, a device that has already been cleared by the FDA through Premarket Notification [510(k)]. The Mixject is used to attach the glass vials containing the biological components for transfer into the syringes without the use of needles. For spraying, the Application Device must be connected through an air tube with a sterile filter to a supply of pressurized gas (compressed air, nitrogen, CO2) via a pressure regulator, which is an accessory to the Application Device. For dripping, the Application Device can be used with or without pressurized gas. The device is ethylene oxide (EtO) sterilized.

The provided text describes a 510(k) premarket notification for the Crosseal™ Application Device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific acceptance criteria in the same way a PMA or de novo submission might.

Therefore, the information available is limited and structured differently from what would typically be presented for a diagnostic AI device requiring a study proving adherence to specific acceptance criteria.

However, I can extract the relevant information based on the sections provided to best answer your request.

Acceptance Criteria and Reported Device Performance for Crosseal™ Application Device

The "acceptance criteria" for this device, in the context of a 510(k), are not explicit numerical targets for diagnostic performance (e.g., sensitivity, specificity). Instead, the studies performed aimed to demonstrate that the device functions as intended and is safe for its indicated use, specifically concerning the application of fibrin sealant. The primary performance criteria revolve around the optimal application parameters for the sealant.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not explicitly state the sample size for the performance testing studies (e.g., how many sprays were tested or how many in vitro tests were performed). For the clinical trials, the number of patients is not specified, only that "Two U.S. pivotal Phase III clinical trials" were conducted.
• Data Provenance:
  • Performance Testing: Not explicitly stated, but implies laboratory testing.
  • Clinical Trials: "Two U.S. pivotal Phase III clinical trials." This indicates retrospective or prospective (likely prospective for Phase III) clinical data from the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this device submission. The "ground truth" here is objective performance (e.g., pressure, distance, biocompatibility results) and clinical outcomes (efficacy of sealant application, absence of adverse events). There is no mention of experts assessing image data or making diagnostic judgments.

4. Adjudication Method for the Test Set

Not applicable. This device is not a diagnostic device requiring adjudication of expert opinions for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an application device for a sealant, not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant to its evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

• For Spray Application Performance: Physical measurements of spray uniformity and consistency, potentially visual inspection, and likely quantitative analysis of sealant distribution in laboratory settings.
• For Biocompatibility: Standardized laboratory assays (e.g., primary skin irritation, guinea pig maximization, cytotoxicity, acute systemic toxicity, pyrogenicity, hemolysis, clotting time) with specific endpoint criteria.
• For Clinical Efficacy: Clinical observations within the Phase III trials, likely involving assessment of sealant coverage and related surgical outcomes, and monitoring for adverse events.

8. The Sample Size for the Training Set

Not applicable. This is not an AI-based device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this information is not relevant.

Ask a specific question about this device